national veterinary services laboratories fm-nahln-0023.03 … · 2019-04-02 · national...
TRANSCRIPT
National Veterinary Services Laboratories
FM-NAHLN-0023.03
Page 2 of 3
REQUEST TO DEVIATE FROM A NAHLN DOCUMENT
USDA, APHIS, VS recognizes that NAHLN laboratories may be requested to deviate from a NAHLN testing standard operating procedure or other NAHLN document. NAHLN Laboratories must submit this completed form to the NAHLN Program Office for approval prior to deviating from the approved use of NAHLN assays.
The completed form must be scanned and e-mailed to: [email protected].
Submitted forms will be reviewed, and the submitting NAHLN Laboratory will receive the signed document (approved or denied) by e-mail.
A. Laboratory Name:
Laboratory Director:
Laboratory Director’s Telephone number:
Laboratory Director’s e-mail Address
B. Date range of planned event (or period of time deviation will be performed):
NAHLN SOP & Version Number (one per form):
NAHLN SOP Name:
C. Description of the proposed planned deviation:
D. Technical justification for the proposed planned deviation:
By signing this form the Laboratory Director is: Requesting a planned deviation from the listed NAHLN Document. Understands the reporting requirements associated with conducting tests off-protocol and will report to the
client that the test used was not validated for the specific deviation. Understands that no deviations are allowed without approval from NVSL. Failure to comply with all
regulations and policies by any party may result in immediate loss of the laboratory’s approval toconduct NAHLN testing.
Understands that this deviation, if approved, will expire upon the release date of a new NAHLN SOP version.It is the requesting laboratory’s responsibility to renew the request to deviate if still needed.
National Veterinary Services Laboratories
FM-NAHLN-0023.03
Page 3 of 3
E. Laboratory
Director’s Review
Signature and date
F. NVSL & NAHLN Review
NVSL Reference Laboratory:
Deviation Approved
Deviation Denied
Justification:
Signature and date
NAHLN Coordinator/ designee:
Deviation Approved
Deviation Denied
Justification:
Signature and date